One of India’s biggest drug makers has a ‘deeply troubling’ pattern of manufacturing problems

For the third time in four months, Lupin Pharmaceuticals, one of India’s biggest suppliers of generic drugs to foreign markets, has been admonished by the Food and Drug Administration for a series of troubling quality-control issues at a manufacturing facility.

In a recent inspection report, the regulator cited the company for failing to thoroughly review unexplained deficiencies in batches of medicines and not taking “scientifically sound” steps to evaluate samples; delays in assessing health hazards; insufficiently investigating customer complaints, including an instance involving mold on medicines shipped to the U.S.; and a lack of oversight and training.

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